Report to the Chairman, Committee on 

Governmental Affairs, U.S. Senate 

United States General Accounting Office 

GAO 

April 2003 SMALLPOX 

VACCINATION 

Implementation of 

National Program 

Faces Challenges 

GAO-03-578 
Implementation of the smallpox vaccination program has proceeded more 

slowly than CDC planned. Vaccinations are to be given to volunteers in two 

stages. CDC’s nationwide target for the first stage was an estimated 500,000 

health workers in 30 days. The number of health workers was based on the 

jurisdictions’ combined targets for their Smallpox Response Teams. In the 

second stage, CDC plans to expand the program to as many as 10 million 

additional health workers and other emergency response personnel. On the 

official start date of vaccination, January 24, 2003, only one state began 

vaccinating. CDC reports that by week 10 (April 4, 2003) about 6 percent of 

the number of volunteers targeted for the first stage had been vaccinated.

Eight states accounted for about half of the vaccinees. Because of the slow 

pace, not enough data were generated by week 10 to evaluate whether the 

program is proceeding as safely as possible. 

Implementation of the program is facing two major challenges. The first is 

the program schedule, which placed heavy demands on CDC and the 

jurisdictions. The second is hesitation on the part of the two main groups 

needed to participate in the program—the state and local public health 

authorities and hospitals needed to implement it, and the health workers 

needed to volunteer to be vaccinated. Many implementers are concerned 

about insufficient resources to support the program and about liability 

protection. Many potential volunteers are concerned about health risks to 

themselves and their co-workers, families, and patients and about 

compensation for adverse events and lost income. 

Program officials and Congress have been working to address some of the 

major challenges but it is too soon to evaluate the impact of these efforts on 

participation in the program. Unless these efforts succeed in overcoming the 

hesitancy of the participants, it may be difficult to achieve the initial targets 

for the first stage. CDC has reconsidered the initial targets and said that as 

few as 50,000 vaccinated health workers nationwide would provide 

sufficient response capacity. But as of late April, CDC had not set a new 

nationwide target or requested that the 62 jurisdictions adjust their targets 

for numbers and types of vaccinated health workers and distribution of 

response teams. CDC also has not said what the implications of this 

potential change in targets for the first stage would be for the second stage. 

In addition, although CDC announced that it would provide guidance for and 

request plans from the jurisdictions for the second stage, it has not yet done 

so. 

Amid growing concerns about a 

potential smallpox attack, the 

Centers for Disease Control and 

Prevention (CDC) is working with 

62 state, local, and territorial 

jurisdictions to implement the 

civilian part of the National 

Smallpox Vaccination Program. 

The goal is to increase the nation’s 

response capacity by vaccinating 

health workers for Smallpox 

Response Teams as quickly as is 

safely possible. A civilian program 

using vaccination to bolster 

bioterrorism preparedness is 

unprecedented, the health risks are 

uncertain, and the public health 

system has had little recent 

experience with smallpox. Safe 

implementation of such a program 

will be complex. GAO was asked to 

examine implementation and its 

challenges. GAO reviewed program 

materials and data and interviewed 

CDC officials and representatives 

of organizations involved. 

GAO recommends that the Director 

of CDC provide guidance to the 

jurisdictions for 

• estimating response capacity 

needs and revising targets for 

the first stage and 

• implementing the second 

stage, that is, vaccination of 

additional health workers and 

other emergency response 

personnel. 

CDC concurred with these 

recommendations. 

www.gao.gov/cgi-bin/getrpt?GAO-03-578.

To view the full report, including the scope 

and methodology, click on the link above. 

For more information, contact Marcia Crosse 

at (202) 512-7119. 

Highlights of GAO-03-578, a report to the 

Chairman of the Committee on 

Governmental Affairs, U.S. Senate 

April 2003

SMALLPOX VACCINATION

Implementation of National Program 

Faces Challenges 
Page i GAO-03-578 National Smallpox Vaccination Program 

Letter 1

Results in Brief 4

Background 6

Implementation Is Slower Than CDC Planned 11

Major Challenges Are Program Schedule and Hesitancy on Part of 

the Two Main Groups Involved in Program 14

Major Challenges Have Not Been Overcome and Continue to Affect 

Implementation 22

Conclusions 24

Recommendations 25

Agency Comments 25

Appendix I Comments from the Centers for Disease Control 

and Prevention 27 

Appendix II GAO Contact and Staff Acknowledgments 29 

GAO Contact 29

Acknowledgments 29

Related GAO Products 30 

Tables 

Table 1: Targets for the First Stage of the Program, as Initially 

Proposed by the 54 Jurisdictions with CDC-Approved 

Plans 8

Table 2: Status of National Smallpox Vaccination Program 

Implementation, Day 1 through Week 10 12

Table 3: Key Events in National Smallpox Vaccination Program 

Time Line as of April 2003 15

Contents 
Page ii GAO-03-578 National Smallpox Vaccination Program 

Abbreviations 

ASTHO Association of State and Territorial Health Officials 

CDC Centers for Disease Control and Prevention 

DOD Department of Defense 

FDA Food and Drug Administration 

HHS Department of Health and Human Services 

HIV human immunodeficiency virus 

HRSA Health Resources and Services Administration 

IOM Institute of Medicine 

NACCHO National Association of County and City Health Officials 

VIG vaccinia immune globulin 

WHO World Health Organization 

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Page 1 GAO-03-578 National Smallpox Vaccination Program 

April 30, 2003 

The Honorable Susan M. Collins 

Chairman 

Committee on Governmental Affairs 

United States Senate 

Dear Chairman Collins: 

On January 24, 2003, four physicians in Connecticut became the first 

civilians in this country to receive the smallpox vaccine—which has not 

been routinely administered in over 30 years—as part of the 

administration’s National Smallpox Vaccination Program. The program, 

which was announced by the President in December 2002, was developed 

in response to growing concern that a terrorist or hostile regime might 

have access to the smallpox virus and attempt to use it as an agent of 

bioterrorism against the American people. In 1980, after a successful 

eradication program, the World Health Organization (WHO) declared the 

world free of naturally occurring smallpox. However, concern remains 

that stockpiles of the virus may exist in laboratories other than the two 

repositories designated by WHO following eradication.1

 Although the 

administration indicated that a terrorist attack involving smallpox is not 

imminent, it determined that the program should proceed as quickly as is 

safely possible. 

The Centers for Disease Control and Prevention (CDC) is charged by the 

Department of Health and Human Services (HHS) with implementing the 

civilian part of the smallpox vaccination program.2

 The goal of the 

program is to increase the nation’s smallpox preparedness capacity by 

offering vaccinations safely to volunteer health workers to increase their 

readiness to respond to a smallpox attack.3

 CDC planned for the 

 1

The two designated repositories are at the Centers for Disease Control and Prevention in 

Atlanta, Georgia, and at the Russian State Centre for Research on Virology and 

Biotechnology in Koltsovo, Russia. 

2

The program also includes provision for the mandatory vaccination of 500,000 Department 

of Defense personnel, primarily those deployed in high-threat areas, and offers vaccination 

on a voluntary basis to State Department personnel deployed in the Middle East. 

3

Centers for Disease Control and Prevention, Supplemental Guidance for Planning and 

Implementing the National Smallpox Vaccination Program (Atlanta, Ga.: Nov. 22, 2002). 

United States General Accounting Office

Washington, DC 20548 
Page 2 GAO-03-578 National Smallpox Vaccination Program 

vaccinations to be carried out in two stages. The first stage began on 

January 24, 2003, the date on which protection against liability for injury 

or death arising from smallpox vaccine administration became effective 

under the Homeland Security Act of 2002 for entities or individuals 

involved in implementing the program.4

 CDC planned that during the first 

stage the vaccine would be offered on a voluntary basis to an estimated 

500,000 public health and health care workers, who would be formed into 

Smallpox Response Teams.5 These teams would be responsible for 

investigating an outbreak following a bioterrorist attack, caring for 

patients, and vaccinating members of the public who may have been 

exposed to the virus. CDC planned to complete the first stage in 30 days. 

During the second stage, the program would be expanded to as many as 10 

million other health care workers, police officers, firefighters, and 

emergency medical technicians, again on a voluntary basis.6

CDC is implementing the smallpox vaccination program in collaboration 

with 62 state, local, and territorial governments.7

 Thus the plan for the 

program is embodied in multiple federal guidance documents and 

recommendations, the individual CDC-approved plans of the 62 

 4

Protected entities and individuals include manufacturers and distributors of certain 

measures to counter bioterrorism using smallpox; hospitals, clinics, and other health care 

entities under whose auspices such measures are administered; and licensed health care 

professionals or other individuals authorized to administer the measures under state law. 

The Homeland Security Act of 2002, which was enacted on November 25, 2002, provides 

that these entities and individuals are to be treated as federal employees for purposes of 

liability arising from the administration of certain measures to counter smallpox under the 

smallpox vaccination program. Therefore the federal government would become the 

defendant in claims for injury or death made in this context. These provisions became 

effective 60 days after enactment. Homeland Security Act of 2002, Pub. L. No. 107-296, § 

304, 116 Stat. 2135, 2165 (2002). 

5

We found in CDC files and statements of federal program officials estimates ranging from 

about 400,000 to about 700,000 health workers to be vaccinated in the first stage. These 

estimates were derived using various assumptions. We have selected the estimate of 

500,000 because it was the one provided to the public in conjunction with the President’s 

announcement of the program. 

6

Although HHS does not recommend vaccination for the general public, it recognized that 

some members of the public may want to be vaccinated and has stated its intention to 

work to accommodate them later in the program. 

7

In addition to the 50 states and the District of Columbia, the 62 jurisdictions include the 

nation’s three largest municipalities, New York City, Chicago, and Los Angeles County, as 

well as the commonwealths of Puerto Rico and the Northern Mariana Islands, American 

Samoa, Guam, the U.S. Virgin Islands, the republics of Palau and the Marshall Islands, and 

the Federated States of Micronesia. 
Page 3 GAO-03-578 National Smallpox Vaccination Program 

jurisdictions, and the plans of thousands of individual hospitals involved. 

Each of the jurisdictions and hospitals has tailored its first-stage planning 

and targets for numbers and distribution of teams and numbers and types 

of health workers on the teams to its own particular circumstances. CDC 

has defined the program’s targets for national preparedness as the sum of 

the targets set by the jurisdictions in their plans. 

A large-scale public vaccination program against a disease that no longer 

exists as a natural threat is unprecedented and presents many challenges. 

The relatively small and known risks of adverse events associated with 

vaccines in past vaccination programs have been justified on the basis of 

the need to reduce a known incidence of disease in the population. For 

smallpox, such justification no longer exists. Both the nature and rates of 

adverse events to be expected in today’s population8

 and the risk of a 

bioterrorist attack are uncertain, making the development and safe 

implementation of a program of smallpox vaccination especially 

challenging. 

In recognition of the potential difficulties in implementation of the 

smallpox vaccination program, you requested that we determine (1) how 

implementation of the civilian part of the program is proceeding, (2) what 

challenges have been encountered, and (3) whether these challenges have 

been addressed. 

In carrying out our work, we conducted a literature review and examined 

program-related materials and data and interviewed officials and 

representatives involved in the program. Specifically, we obtained 

program-related materials and data on plans, numbers of health workers 

vaccinated, shipments of vaccine, adverse events reported, and other 

relevant information from CDC through the first 10 weeks of vaccination. 

We obtained data about the jurisdictions from the Association of State and 

Territorial Health Officials (ASTHO) and the National Association of 

County and City Health Officials (NACCHO). We reviewed relevant 

materials from the Department of Defense (DOD), the Institute of 

Medicine (IOM), WHO, the 62 jurisdictions, and 25 organizations 

representing state and local health authorities, hospitals, physicians, 

 8

Today’s civilian population has a larger proportion of people with compromised immune 

systems due to HIV (human immunodeficiency virus), cancer treatment, and organ 

transplantation, as well as higher rates of some conditions that indicate against smallpox 

vaccination, such as eczema, than the 1960s population from which most of the data about 

smallpox vaccination come. 
Page 4 GAO-03-578 National Smallpox Vaccination Program 

nurses, and other health workers. In addition, we interviewed 

representatives from some of those organizations, including the American 

College of Emergency Physicians, the American Hospital Association, the 

American Nurses Association, ASTHO, NACCHO, and the Service 

Employees International Union, as well as CDC and IOM and selected 

jurisdictional public health officials. We did not systematically review the 

jurisdictional plans nor survey the jurisdictions, and thus we provide 

information about jurisdictions only to illustrate the range of policies and 

activities they encompass. We did not independently verify data provided 

to us by CDC and organizations involved in the program; however, we 

tested the data and determined that they were adequate for our purposes. 

We conducted our work from January 2003 through April 2003 in 

accordance with generally accepted government auditing standards. 

Implementation of the smallpox vaccination program has proceeded more 

slowly than CDC planned. On the start date of vaccination, most of the 62 

jurisdictions were not prepared to begin vaccinating volunteers: More than 

half had not yet requested vaccine from CDC, and most of the remaining 

jurisdictions had requested that their vaccine not be shipped until after the 

start date. On the first day, only one state began vaccinating. As many 

jurisdictions had projected in their individual plans, the vaccination of 

health workers in the first stage of the program is taking longer than the 30 

days set by CDC as an initial target. CDC reports that by week 10 about 6 

percent of the initial target (a total of 31,297 health workers) had been 

vaccinated in 54 of the 62 jurisdictions. Eight states accounted for about 

half of the vaccinees. As of week 10, there are not enough data to precisely 

estimate rates of adverse events and other indicators of program safety. 

Implementation of the program is facing two major challenges—the 

program schedule, which placed heavy demands on CDC and the 

jurisdictions, and hesitation on the part of the two main groups needed to 

participate. CDC developed extensive guidance, training and educational 

programs, and other materials to support implementation, but the 

schedule made it difficult for the agency to resolve all issues prior to the 

start of vaccination. For example, a CDC data system for hospitals to track 

adverse reactions was not available until more than 3 weeks after 

vaccinations had begun. The jurisdictions had less than 3 weeks to 

develop their plans and less than 2 months to prepare to begin vaccination. 

Although generally supportive of the program’s goal, the two major groups 

of participants—the state and local public health authorities and hospitals 

needed to implement it, and the health workers needed to volunteer to be 

vaccinated—have concerns and therefore are hesitating to participate. 

Results in Brief 
Page 5 GAO-03-578 National Smallpox Vaccination Program 

Many implementers are concerned about insufficient resources to support 

the program and about liability protection. Many potential volunteers are 

concerned about safety and protection for themselves and their coworkers, families, and patients and about compensation for adverse events 

and lost income. 

CDC and HHS have been working to address the major challenges, but to 

date they have not been able to overcome them. With regard to the 

challenging program schedule, CDC has reconsidered the initial target of 

vaccination of 500,000 public health and health care workers in 30 days. It 

has said that there is no longer a deadline for the first stage and that as few 

as 50,000 vaccinated health workers nationwide would provide sufficient 

capacity to respond to a smallpox attack. But as of late April, CDC had not 

set a new nationwide target or requested that the 62 jurisdictions adjust 

their targets for numbers and types of vaccinated health workers needed 

to effectively investigate an outbreak, care for patients, and vaccinate 

members of the public with fewer, smaller, or differently distributed 

Smallpox Response Teams. CDC also has not said what the implications of 

this potential change in targets for the first stage would be for the second 

stage involving police, fire, and other workers. In addition, although CDC 

announced that it would provide guidance for and request plans from the 

jurisdictions for the second stage, it has not done so. Program officials 

have also worked to address the concerns impeding participation by the 

implementers and volunteers, but many of these remain unresolved. To 

address the implementers’ concern about resources, HHS announced in 

late March that up to 20 percent of 2003 bioterrorism preparedness 

funding would be available to the jurisdictions immediately upon approval 

of their applications by CDC, but HHS has not yet specified this 

application procedure. In addition, in mid-April Congress appropriated 

other funds to support implementation of the smallpox vaccination 

program. To address the volunteers’ concern about compensation, on 

April 24, 2003, Congress presented legislation to the President for his 

signature that provides benefits to public health and health care team 

members participating in a smallpox emergency response plan and public 

safety personnel who are injured as a result of receiving the vaccine. It is 

too soon to evaluate the impact of these legislative efforts on participation 

in the program. 

We are making recommendations to the Director of CDC to provide 

guidance to the jurisdictions for revising targets for the first stage of the 

smallpox vaccination program and for expansion of the program in the 

second stage. CDC concurred with our recommendations and provided 

information about guidance it is planning to issue. 
Page 6 GAO-03-578 National Smallpox Vaccination Program 

Since the terrorist attacks of September 11, 2001, and the subsequent 

anthrax cases, there has been heightened public awareness and fear of 

potential bioterrorist attacks, including an attack involving smallpox. 

Smallpox is a contagious disease whose symptoms include fever and a 

distinctive progressive skin rash. It is fatal in about 30 percent of cases and 

is considered by CDC to be one of the six biological agents that pose the 

greatest potential threat for adverse public health impact and have a 

moderate to high potential for large-scale dissemination.9

 There is no 

specific treatment for smallpox, but according to CDC it can be prevented 

or its course can be significantly modified in most people through 

vaccination within 3 days of exposure, and vaccination 4 to 7 days after 

exposure will probably offer some protection or may lessen the severity of 

the symptoms.10

The successful use of mass vaccinations to control deadly and debilitating 

diseases worldwide is one of the great public health achievements of the 

past century. Routine immunization programs have been built around safe 

and effective vaccines targeted at smallpox, poliomyelitis, measles, 

rubella, tetanus, diphtheria, influenza, and other infectious diseases. 

Although vaccination programs have provided great benefits, they also 

carry some risk. Most vaccines, like most medications, have a very small 

rate of severe adverse reactions. 

Public vaccination for smallpox began in the United States in the early 

1800s, when Massachusetts began to require smallpox vaccinations for its 

residents. By the late 1800s, smallpox was coming under control in the 

United States as the practice of vaccination became more routine. By the 

1960s, experience had shown that for every 1 million people vaccinated for 

the first time, between 14 and 52 could experience serious and potentially 

life-threatening adverse events and 1 to 2 could die. But these risks were 

deemed acceptable to control this contagious and often fatal disease. By 

1972 the risk of smallpox in the United States was sufficiently remote that 

routine vaccinations were discontinued, 8 years before WHO’s 

announcement that the disease had been eradicated worldwide. 

 9

The other agents in the group are anthrax, botulism, plague, tularemia, and viral 

hemorrhagic fevers. 

10Centers for Disease Control and Prevention, Smallpox Fact Sheet: Vaccine Overview 

(Atlanta, Ga.: Dec. 9, 2002). 

Background 

Role of Vaccination in 

Public Health 

Smallpox Vaccination 
Page 7 GAO-03-578 National Smallpox Vaccination Program 

Immunity to the virus that causes smallpox—the variola virus—is 

conferred through inoculation with a vaccine made from the closely 

related vaccinia virus. The smallpox vaccine does not contain the variola 

virus and cannot cause smallpox. The smallpox vaccine is a “live virus” 

vaccine; that is, the vaccinia virus it contains is living and may produce 

mild reactions, including rash, fever, and head and body aches.11 In certain 

groups of people, including those with compromised immune systems and 

certain skin conditions such as eczema, adverse events associated with the 

vaccine can be severe. Because the virus is live, it can be transmitted to 

other parts of the body or to other people, who could also face potentially 

serious complications, and so care has to be taken to minimize the risk of 

spreading the vaccinia virus from the vaccination site.12 Previous 

experience with the vaccine has shown that it spreads to other parts of the 

vaccinee’s body at a rate of 25 to 532 per million individuals vaccinated 

and spreads from the vaccinee to others at a rate of 20 to 60 per million. 

The National Smallpox Vaccination Program is unique in the history of 

civilian immunization programs in that it is not a public health program in 

the traditional sense but rather a program of bioterrorism preparedness. 

The population to be vaccinated in the first and second stages of the 

civilian part of the program is not the general public as in traditional 

programs, but key public health, health care, and emergency response 

workers. Smallpox Response Teams vaccinated in the first stage would 

receive vaccine not solely to protect their own health but primarily to 

increase the nation’s capacity to respond to a smallpox attack by 

investigating an outbreak, caring for patients, and vaccinating members of 

the public who may have been exposed. Because vaccination soon after 

exposure can prevent or reduce the severity of the disease, planners 

project that there will be sufficient time for these key workers to vaccinate 

members of the public as needed to contain a smallpox outbreak after it 

has been recognized. 

CDC’s guidance allows the 62 jurisdictions some flexibility in forming their 

Smallpox Response Teams. For example, it provides recommendations for 

 11Live virus vaccines, like all other licensed vaccines, are considered safe and effective for 

most people with healthy immune systems. Other live virus vaccines include those for 

measles, mumps, rubella, and chickenpox. 

12For more information on smallpox and the smallpox vaccine, see CDC’s smallpox fact 

sheets at http://www.cdc.gov/smallpox. 

The National Smallpox 

Vaccination Program 
Page 8 GAO-03-578 National Smallpox Vaccination Program 

the types of workers to be included in the two types of Smallpox Response 

Teams—the Public Health Smallpox Response Teams and the Healthcare 

Smallpox Response Teams—but leaves the numbers of workers and exact 

composition of teams to the jurisdictions to decide on the basis of their 

particular needs. For the public health teams, which are based at state and 

local public health agencies, the guidance states that each team should 

have a medical expert as team leader and should include public health 

advisors, medical epidemiologists, disease investigators, laboratory 

workers, nurses, and vaccinators. For the health care teams, which are 

based at hospitals, the criteria for choosing which health care workers to 

include are to be developed locally. Each jurisdiction was to have formed 

at least one public health team and as many other public health and health 

care teams as it deemed necessary by 30 days from the announced start 

date of vaccination. The jurisdictions’ plans vary widely in terms of the 

time line for the first stage of vaccination and their targets for the numbers 

of teams and workers to be vaccinated (see table 1). The jurisdictions with 

CDC-approved plans proposed to vaccinate 1,101 public health teams and 

4,532 health care teams, for a total of 415,691 vaccinated volunteers 

nationwide.13 Although CDC had called for the first stage of vaccinations to 

be completed in 30 days, many jurisdictions expected vaccinations to take 

longer than that to complete. 

Table 1: Targets for the First Stage of the Program, as Initially Proposed by the 54 

Jurisdictions with CDC-Approved Plans 

 Targets 

Average Minimum Maximum

Planned duration of first stage (in days) 55 7 126 

Planned number of Public Health Smallpox 

Response Teams 21 1 107 

Planned number of Healthcare Smallpox Response 

Teams 92 2 375 

Planned number of volunteers to be vaccinated 7,997 323 40,000 

Planned number of volunteers to be vaccinated per 

million population 1,903 81 8,772 

Source: GAO analysis of CDC data. 

Note: The plans for the territories had not been approved as of January 2003. 

 13The plans for the territories were not yet approved when CDC derived these figures, 

which therefore represent the totals from the plans for the 50 states, the District of 

Columbia, New York City, Chicago, and Los Angeles County. 
Page 9 GAO-03-578 National Smallpox Vaccination Program 

CDC has said that safety is the top priority in implementing this program. 

To enable jurisdictions to implement this program in the safest manner 

possible, the agency has provided guidance and materials for critical 

elements of the program, including 

• education and training of health workers who will be administering the 

vaccinations; 

• education and screening of volunteers to rule out those who may be at 

greater risk for severe reactions; 

• care of the site of vaccination on the vaccinee’s body to prevent secondary 

infection or transmission to others; 

• monitoring of adverse events; 

• distribution of the two investigational drugs used in treating certain 

adverse reactions caused by the vaccine, vaccinia immune globulin (VIG) 

and cidofovir14; and 

• systems for ongoing collection, management, and analysis of program 

data—including adverse events,15 transmissions of the vaccinia virus to 

individuals the vaccinee was in contact with following the vaccination (or 

“secondary transmission”), requests for VIG or cidofovir, needlestick 

injuries to vaccinators,16 and vaccine wastage—to evaluate the program 

and make adjustments as necessary. 

In addition, CDC is sponsoring an advisory group, the IOM Committee on 

Smallpox Vaccination Program Implementation, to provide advice to 

program officials at CDC on selected aspects of program implementation, 

including guidelines and instruments for screening; measures to ensure 

the early recognition, evaluation, and appropriate treatment of adverse 

events; plans for collecting and analyzing data; and the achievement of 

 14VIG, which is recommended as the first line of therapy, and cidofovir are available for 

civilians only through CDC following consultation with CDC staff. 

15Most of these systems are passive surveillance systems, which rely on patients or staff 

involved in their care to take the initiative to provide data. Adverse events that require 

hospitalization or outpatient care (such as encephalitis, eczema vaccinatum, progressive 

vaccinia, and inadvertent inoculation) are being tracked by CDC and state health 

departments primarily using the Vaccine Adverse Events Reporting System, which is a 

passive system. CDC expects adverse events of this kind to be well captured by a passive 

system, but less severe adverse events that do not require treatment (such as low-grade 

fever, headache, mild skin rash, and nausea) to be underreported. 

16Procedures involving needles pose the risk that either the person using the needle or 

someone involved in its disposal will be unintentionally stuck, thereby potentially coming 

in contact with whatever substance the needle delivered and the blood of the person on 

whom it was used. 
Page 10 GAO-03-578 National Smallpox Vaccination Program 

overall goals of the smallpox vaccination program. This committee has 

issued two of a planned series of reports. 

Originally, the program had no provisions to compensate anyone for lost 

time from work, health care costs, disability, or death due to adverse 

events. Instead, it was expected that workers would be covered by 

existing mechanisms such as workers’ compensation and insurance. 

The initial federal funding for the smallpox vaccination program came 

from CDC’s bioterrorism preparedness funding. Since fiscal year 1999, 

HHS has distributed funding for bioterrorism preparedness to state and 

local health departments in the 62 jurisdictions primarily through CDC’s 

Bioterrorism Preparedness and Response Program.17 In January 2002, HHS 

announced the availability of supplemental funding through the CDC 

program and a Health Resources and Services Administration (HRSA) 

program. Under the CDC program, $918 million in supplemental funding 

was made available to jurisdictions for general bioterrorism 

preparedness.18 HHS required jurisdictions to submit their applications for 

these funds by April 15, 2002. Each jurisdiction was to develop a plan 

during 2002 to improve general bioterrorism preparedness within six 

categories: preparedness planning and readiness assessment, surveillance 

and epidemiology capacity, laboratory capacity for biological agents, 

communications and information technology, risk communication and 

health information dissemination, and education and training. At the same 

time, under the Bioterrorism Hospital Preparedness Program, HRSA made 

$125 million available through cooperative agreements to the jurisdictions 

to enhance the capacity of hospitals and associated health care entities to 

respond to bioterrorist attacks, as well as other public health emergencies. 

In March 2002, CDC announced the extension of its Bioterrorism 

Preparedness and Response Program through August 2005, without 

indicating whether additional funds would be available. On November 22, 

 17U.S. General Accounting Office, Bioterrorism: Federal Research and Preparedness 

Activities, GAO-01-915 (Washington, D.C.: Sept. 28, 2001). Also see the “Related GAO 

Products” section at the end of this report. 

18The funds were appropriated by the Department of Defense and Emergency Supplemental 

Appropriations for Recovery from and Response to Terrorist Attacks on the United States 

Act, Pub. L. No. 107-117, 115 Stat. 2230, 2314 (2002), and the Department of Health and 

Human Services and Education, and Related Agencies Appropriations Act for Fiscal Year 

2002, Pub. L. No. 107-116, 115 Stat. 2186, 2198 (2002). 

Initial Federal Funding for 

the Smallpox Vaccination 

Program 
Page 11 GAO-03-578 National Smallpox Vaccination Program 

2002, CDC notified the jurisdictions that they were to plan and implement 

the National Smallpox Vaccination Program by utilizing and redirecting 

the monies previously disbursed under the Bioterrorism Preparedness and 

Response Program. These plans for the first stage of smallpox vaccination 

were due to CDC on December 9, 2002. 

Implementation of the smallpox vaccination program has proceeded more 

slowly than CDC planned. Because of the slow pace, not enough data have 

been generated to determine whether implementation is proceeding as 

safely as possible according to the program’s goal. 

Specifically, vaccination of health workers in the first stage has proceeded 

slowly. CDC’s initial target date for completion of the first stage has 

passed. As of the start date for vaccination, January 24, 2003, most of the 

jurisdictions were not ready to begin vaccinating: More than half of the 

jurisdictions had not yet requested vaccine from CDC, and most of the 

remaining jurisdictions had requested that their vaccine not be shipped 

until after the start date. (See table 2.) On the first day, four health care 

workers in one jurisdiction—Connecticut—were vaccinated. As many 

jurisdictions had projected in their individual plans, the vaccination of 

health workers in the first stage of the program is taking longer than the 30 

days set by CDC as an initial target. By the end of the tenth week, April 4, 

2003, 7 jurisdictions had yet to request vaccine, but the rest had requested 

and received their shipments. Although CDC reported that a total of 31,297 

health workers (about 6 percent of the initial target) had been vaccinated 

in 54 of the 62 jurisdictions by week 10, about half of those vaccinated 

were distributed across eight states: Florida, Minnesota, Missouri, 

Nebraska, North Carolina, Ohio, Tennessee, and Texas. Sixty-two percent 

of those vaccinated were Healthcare Smallpox Response Team members, 

and 33 percent were Public Health Smallpox Response Team members; 

the remaining 4 percent were “other,” which includes public officials who 

are not part of a Smallpox Response Team.19 As of late April, CDC did not 

have information about the number of complete response teams formed. 

As of week 10, CDC reported that roughly one-third of an estimated 5,000 

acute care hospitals in the jurisdictions began vaccinations. Almost half of 

these hospitals are in seven jurisdictions: Florida, Louisiana, Missouri, 

Nebraska, Ohio, Tennessee, and Texas. 

 19Due to rounding, the percents do not total to 100. 

Implementation Is 

Slower Than CDC 

Planned 
Page 12 GAO-03-578 National Smallpox Vaccination Program 

Table 2: Status of National Smallpox Vaccination Program Implementation, Day 1 

through Week 10 

As of day 1 

(January 24, 2003) 

As of week 4 

(February 21, 2003) 

As of week 10

(April 4, 2003)

Number 

(percent) of 

jurisdictions that 

had requested 

vaccinea

27 (44%) 52 (84%) 55 (89%)

Number 

(percent) of 

jurisdictions that 

had received 

vaccinea

8 (13%) 52 (84%) 55 (89%)

Number 

(percent) of 

jurisdictions that 

had initiated 

vaccinationsa

 1 (2%) 40 (65%) 54 (87%)

Number 

(percent) of 

volunteers 

vaccinatedb 4 (<1%) 7,354 (<2%) 31,297 (6%)

Source: CDC. 

a

Percent of total of 62 jurisdictions. 

b

Percent of initial estimated target of 500,000. 

Because progress has been slow, to date there are not enough data to 

precisely gauge indicators of the safety of implementation. For example, 

too few health care workers have been vaccinated and too little time has 

passed since their vaccination to precisely estimate rates of adverse 

events. Therefore it cannot yet be determined whether the rates are the 

same as would have been anticipated on the basis of historical data or 

different enough to trigger reconsideration of how the program should 

proceed. As of April 4, 2003, CDC had received reports of 68 moderate to 

severe adverse events20 and 250 less severe adverse events, such as fever 

and rash, potentially related to smallpox vaccination. In addition, CDC had 

received reports that two volunteers who had been vaccinated died of 

heart attack, but CDC has not yet determined whether the deaths were 

 20These reports include cases of generalized vaccinia, inadvertent inoculation, myocarditis, 

pericarditis, and ocular vaccinia, but no reports of other severe adverse events, such as 

progressive vaccinia, eczema vaccinatum, encephalitis, encephalomyelitis, or vaccinia 

transmission. 
Page 13 GAO-03-578 National Smallpox Vaccination Program 

related to the smallpox vaccine.21 CDC officials maintain that the low 

number of severe adverse events associated historically with smallpox 

vaccination strongly suggests that screening efforts and measures to 

prevent transmission of vaccinia virus to contacts have been effective. 

However, the experience of more vaccinees would have to be examined in 

order to derive precise rates of how often the rare but most severe adverse 

events occur.22 Further, because more than half of the individuals were 

vaccinated during weeks 6 through 10, some of the adverse events that can 

occur weeks after vaccination would not yet have been detected. 

Moreover, not all planned vaccination monitoring systems were in place 

until more than 3 weeks after vaccination began, and some jurisdictions 

report ongoing difficulties in using the systems required by CDC.23

Therefore some of the experience to date may not have been captured by 

these systems. 

The data obtained as of week 10 are also insufficient to answer other 

important safety questions. For example, although CDC had reported no 

needlestick injuries as of late April, too few vaccinations have been given 

 21CDC announced on March 25, 2003, that volunteers with heart disease should not be 

vaccinated until further notice. CDC also issued modified smallpox vaccination program 

implementation materials that reflected this new exclusion. Nine states announced that 

they were temporarily suspending their vaccination programs until the new guidance was 

released. As of late April, all but two of these states had resumed vaccinations. 

22DOD has reported on experience with vaccinating over 350,000 personnel as of March 31, 

2003, more than 8,000 of which were health care workers. As of that date, DOD reports 82 

adverse events and that 3 percent of vaccinees took an average of 1.5 days of sick leave. 

DOD also reports that one vaccinee died of heart attack but states that smallpox 

vaccination was unlikely to be the cause of death. Although the DOD experience is 

informative and DOD is sharing information with HHS, the military program differs from 

the civilian one in several respects that limit the ability to generalize results from one 

program to the other. For example, the DOD program is not voluntary, the military setting 

provides more options for keeping vaccinated personnel separated from others, and the 

military population is on average younger than the general population. Thus, for example, 

data from the DOD program could contribute to understanding the rates of adverse events 

in properly screened vaccinees, but would have less relevance for determining the 

effectiveness of the educational and screening process for volunteers in the civilian 

program. 

23CDC developed the voluntary, Web-based Hospital Smallpox Vaccination Monitoring 

System for hospitals to track such indicators as workdays lost and symptoms reported by 

vaccinees (ranging from mild to severe), but that system was not available until 

February 18, 2003. Because this system is designed to be used by hospitals to track 

vaccinees in real-time, it could be part of an active surveillance system. In contrast to a 

passive system, an active surveillance system would seek out the vaccinees to collect data 

on them. 
Page 14 GAO-03-578 National Smallpox Vaccination Program 

to precisely estimate the rate of such injuries. Similarly, there are not 

enough data to evaluate the effectiveness of the screening process, the 

effectiveness of measures to prevent the spread of vaccinia virus, the 

safety and effectiveness of VIG and cidofovir, and the effectiveness of 

CDC’s distribution system for these investigational drugs.24

Implementation of the smallpox vaccination program is facing two major 

challenges. One is the program schedule, and the other is hesitancy on the 

part of the two main groups involved in the program—those needed to 

implement it and those needed to volunteer to be vaccinated. 

Although these two groups have generally expressed support for the goals 

of the program, they have concerns regarding the availability of resources 

to implement the program, liability protection, safety, and workers’ 

compensation. 

The program schedule is challenging and has placed heavy demands on 

CDC and the jurisdictions (see table 3). CDC has developed a wide range 

of implementation materials, which it has distributed through multiple 

channels. These materials include guidance documents and educational 

and training programs. The effort to produce materials quickly has led to 

difficulties. Some of the materials that were distributed needed to be 

revised, and some were inconsistent or untested. Some key materials were 

not available until after the start of vaccination. For example, the package 

of materials to be used to obtain informed consent for vaccination from 

volunteers was first made available 8 days before the start of vaccination, 

and the revised version was issued the day before vaccination was to start. 

The delayed availability of these materials created difficulties for those 

trying to implement the program. In addition, CDC has provided 

conflicting information about the precise method for administering the 

vaccine. Further, the materials used to educate and screen volunteers 

were not tested for comprehensibility to ensure that the screening process 

would function as intended. Moreover, while CDC provided preliminary 

guidance for adverse event monitoring in November, it hosted training on 

this issue 2 days before the program began and did not issue detailed 

guidance about the adverse event monitoring system until 2 weeks after 

vaccination had begun. 

 24CDC reports that it shipped VIG to two states and made no shipments of cidofovir. 

Major Challenges Are 

Program Schedule 

and Hesitancy on Part 

of the Two Main 

Groups Involved in 

Program 

Program Schedule Has 

Challenged CDC and the 

Jurisdictions 
Page 15 GAO-03-578 National Smallpox Vaccination Program 

Table 3: Key Events in National Smallpox Vaccination Program Time Line as of 

April 2003 

Date Event 

November 22, 2002 • CDC issued guidance to jurisdictions for developing 

plans for first stage of vaccination. 

November 25, 2002 • Homeland Security Act of 2002 enacted. 

December 9, 2002 • Jurisdictional plans for first stage were due to CDC. 

December 12, 2002 • CDC completed initial review of jurisdictional plans for 

first stage. 

December 13, 2002 • President announced National Smallpox Vaccination 

Program. 

December 18-20, 2002 • CDC-sponsored IOM Committee on Smallpox 

Vaccination Program Implementation held first meeting. 

January 16, 2003 • CDC-sponsored IOM Committee on Smallpox 

Vaccination Program Implementation issued first report. 

January 21, 2003 • Jurisdictions that requested vaccine began receiving 

smallpox vaccine from CDC. 

January 24, 2003 • Liability provisions of Homeland Security Act of 2002 

went into effect. 

• HHS authorized start of vaccination program. 

• First stage of vaccination began. 

February 13-14, 2003 • CDC-sponsored IOM Committee on Smallpox 

Vaccination Program Implementation held second 

meeting. 

February 22, 2003 • CDC’s original target date for completion of first stage of 

vaccination. 

March 21, 2003 • CDC-sponsored IOM Committee on Smallpox 

Vaccination Program Implementation issued second 

report. 

April 16, 2003 • President signed Emergency Wartime Supplemental 

Appropriations Act, 2003, which includes additional 

funding that can be used for smallpox vaccination 

program. 

April 24, 2003 • Congress presented H.R. 1770, Smallpox Emergency 

Personnel Protection Act of 2003, to President for his 

signature. 

Source: HHS, IOM, and the Library of Congress. 

The program schedule has pressured the advisory process that CDC has 

set up through IOM to help ensure that the program achieves its goals 

safely, and the advisory committee has been concerned that the schedule 

might not allow for a thorough evaluation of the program. Little time was 

available for IOM’s Committee on Smallpox Vaccination Program 

Implementation to undertake its first review and for CDC to respond to the 

committee’s first report, which was issued 8 days before the start of the 
Page 16 GAO-03-578 National Smallpox Vaccination Program 

vaccination effort.25 Consequently, many of the IOM recommendations that 

relate to ensuring the safety of the program and facilitating 

implementation had not been addressed at the start of vaccination. For 

example, the IOM committee recommended that the materials to be used 

to screen volunteers be pretested for comprehensibility before vaccination 

started, but CDC responded that the schedule of the program precluded 

such testing and initiated vaccination with the untested screening 

materials. To ensure that the program proceeds safely, IOM also called for 

a thorough evaluation by IOM and others following the first stage, prior to 

beginning the second stage, as one of its key recommendations. CDC has 

said that because of the need to implement the program rapidly there is no 

distinction between the first and second stages and it does not expect to 

identify a formal end to the first stage. Instead, CDC expects that 

evaluation will be ongoing. In its second report, IOM reiterated its concern 

that a too rapid expansion of the program could preclude the opportunity 

to learn from the first stage before proceeding, and it again urged CDC to 

comprehensively evaluate the smallpox vaccination program and its 

outcomes in order to improve its implementation and to protect the 

vaccinees and the public.26

The program schedule has also placed heavy demands on the jurisdictions. 

CDC required the jurisdictions to develop plans and targets for the first 

stage of vaccination in less than 3 weeks. It provided some guidance on 

the types of workers to be vaccinated on each type of team, but no 

guidance for estimating the number of workers on teams or the number 

and distribution of teams within a jurisdiction needed to provide sufficient 

smallpox response capacity.27 CDC expected the jurisdictions to be ready 

to begin vaccinating less than 2 months after it approved their plans. The 

jurisdictions are dependent on the guidance, educational and training 

programs, and other materials produced by CDC, but these materials have 

been changing since the program started. In accord with IOM’s 

recommendation, some jurisdictions have also indicated that they would 

 25Institute of Medicine, Committee on Smallpox Vaccination Program Implementation, 

Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination 

Program Implementation: Letter Report #1 (Washington, D.C.: Jan. 16, 2003). 

26Institute of Medicine, Committee on Smallpox Vaccination Program Implementation, 

Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination 

Program Implementation: Letter Report #2 (Washington, D.C.: Mar. 21, 2003). 

27CDC’s guidance on the types of workers to be vaccinated for health care teams was not 

formalized until February 26, 2003. 
Page 17 GAO-03-578 National Smallpox Vaccination Program 

benefit from an evaluation of the first stage of the program before 

proceeding to the second. CDC has indicated that the jurisdictions are to 

proceed to the second stage as they determine they are ready to do so. 

However, CDC has not provided guidance to help them plan and 

implement the second stage of the program. 

The smallpox vaccination program is to be implemented in the 

jurisdictions by state and local public health authorities and individual 

hospitals. But these implementers are hesitating to participate in the 

program because of concerns about adequacy of resources and liability 

protection. 

State and local health officials have stated that they are committed to the 

safe and timely implementation of the smallpox vaccination program; 

however, some have expressed concerns about the availability of 

resources to implement this program. CDC initially provided no cost 

estimates, but in testimony given in late January the Director estimated the 

basic cost of administering the vaccine at $13 per vaccinee.28 State and 

local health officials assert that CDC has underestimated the cost of 

planning and implementing the program. According to recent ASTHO and 

NACCHO surveys, estimates of the cost of the whole first-stage 

vaccination process—from planning through follow-up—range from $79 to 

$1,784 per vaccinee.29 ASTHO and NACCHO estimate that the average cost 

per vaccinee is $265 and $204, respectively. CDC expects jurisdictions to 

redirect funds made available through bioterrorism cooperative 

agreements to pay for the smallpox vaccination program. However, state 

and local health officials report that as of March 2003 most of these funds 

were already committed to other bioterrorism activities; on average only 7 

percent of these funds remain available. Thus in order to meet the 

 28Statement of Director, Centers for Disease Control and Prevention, Department of Health 

and Human Services, before the Senate Subcommittee on Labor, Health and Human 

Services, Education and Related Agencies, Committee on Appropriations, Hearing on 

Implementation of Smallpox Vaccination Plan, 108th Cong., 1st sess. (Jan. 29, 2003), and 

Statement of Director, Centers for Disease Control and Prevention, Department of Health 

and Human Services, before the Senate Committee on Health, Education, Labor, and 

Pensions, Hearing on the Administration’s Smallpox Vaccination Plan: Challenges and 

Next Steps, 108th Cong., 1st sess. (Jan. 30, 2003). 

29In addition to the costs for administration of the vaccine, these estimates include costs 

such as planning, education, training, screening, communication, data management, 

vaccine clinic implementation, monitoring of the vaccination site, surveillance, and 

treatment of adverse events. 

Implementers and 

Organizations That 

Represent Them Are 

Hesitating to Participate 

Because of Concerns 

about Adequacy of 

Resources and Liability 

Protection 
Page 18 GAO-03-578 National Smallpox Vaccination Program 

demands of the smallpox vaccination program, they would need to divert 

funds supporting other bioterrorism preparedness efforts and other public 

health services. According to a recent NACCHO survey, about 79 percent 

of local public health agency respondents reported that smallpox work is 

adversely affecting their other bioterrorism preparedness efforts. About 53 

percent reported that resources for other public health services such as 

childhood immunization have been diverted to smallpox and other 

bioterrorism efforts. ASTHO and some of the jurisdictions have told us 

that although they are working to manage the first stage of smallpox 

vaccination by diverting resources from other efforts, they anticipate that 

it will be difficult if not impossible to find resources to implement the 

second stage. 

Organizations representing hospitals have indicated that hospitals are 

generally committed to participating in the program, but many have 

concerns about inadequate resources and about the balance between the 

risks and benefits of vaccination. Hospitals are concerned that they may 

have to assume the costs of implementing the program and note that they 

lack adequate resources to do so. Hospitals include in their cost 

calculations staff time to receive, administer, and follow up on 

vaccinations; materials (e.g., forms) and supplies (e.g., bandages); 

treatment for adverse events; and sick leave. Hospitals contend that the 

$125 million previously provided by HRSA to states for use on the creation 

of regional hospital response plans has proved insufficient for that 

purpose and cannot cover the additional costs of the smallpox vaccination 

program. However, resources are not the primary concern for all hospitals. 

Hundreds of hospitals have opted not to participate in the smallpox 

vaccination program at this time, contending that the risks outweigh the 

benefits. Because the administration has characterized the threat of a 

smallpox attack as being low, some hospitals estimate that the 

countervailing risks to their patients of vaccinating hospital staff are too 

great. These hospitals have indicated that they would reconsider their 

decisions regarding participation should the risk of an attack increase or 

cases of smallpox appear. 

State and local health officials and hospital representatives are also 

concerned about the scope of liability protection provided by the 

Homeland Security Act of 2002 and have requested clarification. These 

officials are requesting amendments to the act that would provide explicit 

liability protection to vaccination program participants not specifically 

protected by the act, such as public health departments and public health 

workers. In addition, since the act provides no apparent protection for 

entities that do not participate in the smallpox vaccination program, 
Page 19 GAO-03-578 National Smallpox Vaccination Program 

hospital representatives are concerned that a nonparticipating hospital, for 

example, may not be protected if one of its health care workers who was 

vaccinated elsewhere transmits vaccinia virus to one of its patients.30

Many of the organizations that represent the public health and health care 

workers who are needed to volunteer to be vaccinated have expressed 

their willingness to participate in the smallpox vaccination program. 

However, they have concerns about the possibility of experiencing 

adverse reactions to the vaccine, ranging from fatigue to death, and the 

possibility of transmitting the vaccinia virus to coworkers, family 

members, or patients who could also face mild to severe complications. 

They also have concerns about compensation for such injuries. 

Volunteers are concerned about the adequacy of CDC’s screening process 

for ruling out volunteers with conditions that may put them at greater risk 

for severe reactions. For example, CDC recommends screening volunteers 

for pregnancy or HIV, either of which can put a volunteer at greater risk. 

However, volunteers do not believe they should have to undertake the 

effort and expense to independently be tested for these conditions. The 

provision of free testing for these risk factors as part of the screening 

process is left to the discretion of the individual participating jurisdictions 

and institutions. Volunteers are concerned that the lack of free, routine 

testing could hinder identification of potential vaccinees who may not be 

aware that they are pregnant or have HIV. 

Volunteers who work in hospitals are concerned about the possibility of 

transmission of vaccinia virus to their patients. CDC asserts that following 

optimal infection control practices, such as using special bandages and 

checking them daily, wearing clothing that covers the vaccination site, and 

hand washing, should essentially eliminate the risk of vaccinated health 

care workers transmitting vaccinia virus to patients. Therefore, CDC 

guidance does not require that vaccinated workers be kept separate from 

patients until they can no longer transmit vaccinia virus. Volunteers are 

uncertain whether the practices that CDC recommends will be sufficient. 

Moreover, it is left to the individual participating jurisdictions and 

 30Although the Secretary of HHS issued a letter implying protection for such a hospital, the 

Secretary’s Declaration Regarding Administration of Smallpox Countermeasures 

indicates that hospitals would receive protection from liability under the act if they 

designate employees to receive the vaccine. It is unclear whether nonparticipating 

hospitals are in a position to make such designations. 68 Fed. Reg. 4212, 4213 (2003). 

Volunteers and 

Organizations That 

Represent Them Are 

Primarily Concerned about 

Safety and Compensation 

for Injury 
Page 20 GAO-03-578 National Smallpox Vaccination Program 

hospitals to determine whether any leave taken to avoid contact with 

patients will be paid for by the institution or the health care worker. Thus, 

workers are concerned that they may lose income if they choose or are 

required to be kept separate from patients. 

Nursing associations and unions representing health care workers are 

concerned about the two-pronged needle that CDC provides for use with 

the smallpox vaccine, noting that it lacks safety features such as a 

protective sheath available with other needles.31 Health care workers 

assert that the needles being used in the program may increase the risk of 

needlesticks and exposure to the blood of vaccinees, both for those 

administering the vaccine and for those along the path of needle disposal.32

They have recommended that an alternative needle with safety features be 

used instead. CDC has stated that it does not provide these alternative 

needles because it has determined that no commercially available safetyengineered two-pronged needle is an appropriate replacement for the one 

included in the prepackaged kit it is distributing for the smallpox 

vaccination program. 

Many of the organizations representing health care workers have 

expressed support for the goal of the program. However, in the literature 

some individual physicians have questioned the program and raised 

concerns that the risks of smallpox vaccination to workers, their families, 

and patients may outweigh the benefits to society of preparedness for a 

smallpox attack. Like some hospital administrators, these physicians are 

recommending against vaccination at this time because program officials 

have characterized the risk of an attack with smallpox as very low and 

because there is a window in which vaccination is effective even after 

exposure. They too have indicated that they would reconsider their 

decision should the risk of smallpox increase. 

The decision that health care workers face about whether to be vaccinated 

is further complicated by potentially confusing educational and screening 

 31The Dryvax vaccine kit approved for use by the Food and Drug Administration (FDA) in 

the current smallpox vaccination program includes 100 two-pronged needles produced by 

the original manufacturer of the two-pronged needle. A different manufacturer produces an 

FDA-approved two-pronged safety needle, which has a plastic sheath that slides forward 

after use to cover the tip of the needle and prevent injury. 

32See also U.S. General Accounting Office, Occupational Safety: Selected Cost and Benefit 

Implications of Needlestick Prevention Devices for Hospitals, GAO-01-60R (Washington, 

D.C.: Nov. 17, 2000). 
Page 21 GAO-03-578 National Smallpox Vaccination Program 

materials for volunteers. For example, some CDC materials specifically 

mention that certain asthma patients who are taking immune-suppressing 

drugs should be excluded. Other CDC materials screen out asthma 

patients for different reasons, and still others do not mention asthma 

patients at all. The differences in these materials may create confusion for 

individuals with asthma who are trying to determine if they should be 

excluded from vaccination. Also, because each jurisdiction can tailor some 

of the guidance and materials provided by CDC according to its own 

judgment, health care workers who live and work in separate jurisdictions 

could receive inconsistent materials. For example, CDC does not 

recommend against vaccinating individuals with an infant at home, but 

some jurisdictions have decided to exclude such volunteers from 

vaccination because of the seriousness of vaccinia virus in infants. 

Organizations representing health workers are further concerned about 

whether the costs to volunteers and their families would be covered 

should they experience an adverse event and require time off from work,33

need medical treatment, become disabled, or die. HHS officials have stated 

that they expect costs due to adverse events to be covered by sick leave, 

workers’ compensation, or individual, institutional, or jurisdictional 

insurance policies. However, sick leave benefits vary from institution to 

institution, and thus some workers may lose income. Health care coverage 

also varies by institution and by policy, and thus not all volunteers are 

guaranteed to have coverage for the costs of treating their adverse 

reactions. For example, sick volunteers may have to pay co-payments for 

medical care. In addition, ASTHO has surveyed states and found wide 

variation in workers’ compensation programs. Some states anticipate that 

vaccinated volunteers will be covered under their workers’ compensation 

programs. However, given that workers’ compensation eligibility is 

determined on a case-by-case basis, many states refrain from generalizing 

about such coverage. Even when applicable, workers’ compensation may 

provide only a percentage of salary and may not provide coverage for 

individuals who received vaccinia virus from a vaccinated volunteer. 

 33Based on available data, CDC estimates that, among properly screened volunteers, onethird of vaccinees will experience mild to moderate reactions that may cause them to miss 

at least 1 day of work. 
Page 22 GAO-03-578 National Smallpox Vaccination Program 

CDC and HHS have been working to address the major challenges of 

program schedule and hesitancy of participants, but to date they have not 

been able to overcome them. With regard to the challenging program 

schedule, CDC has reconsidered whether the initial targets for time for 

completion and the total number of vaccinated health care workers are 

required to achieve the goal of preparedness. Although CDC has said that 

it expected the first stage to take more than 30 days, it has not set a new 

target for completion of the first stage. The Director of CDC has stated, 

however, that it may not be necessary to vaccinate 500,000 health care 

workers to achieve the goal of preparedness. She has indicated that as few 

as 50,000 would suffice but has not explained how CDC arrived at that 

number. CDC has not said how these workers should be organized and 

distributed within the Smallpox Response Teams and across the nation. As 

of late April, CDC had yet to set new targets for the first stage or to request 

that the jurisdictions reconsider their plans to meet new targets. Most of 

the jurisdictions have initiated the first stage of vaccination as they had 

originally planned, although many have started later and have vaccinated 

fewer workers than they anticipated. Some jurisdictions have indicated 

that they are attempting to follow their original plans while awaiting 

resolution of the liability and compensation issues, and others have said 

that they have begun to revise their targets downward for the first stage 

without waiting for a request from CDC. 

CDC has not said what the implications of this potential change in targets 

for the first stage would be for the second stage. In addition, although CDC 

announced that it would provide guidance for and request plans from the 

jurisdictions for the second stage, it has not done so. Thus the 

jurisdictions cannot determine how the workers to be vaccinated in the 

second stage will be used to expand response capacity. Specifically, they 

do not have guidance for how they should estimate their targets for the 

types, number, and distribution of the additional workers to be vaccinated. 

CDC and HHS have made some progress in addressing the two major 

concerns regarding resources and liability that are contributing to the 

hesitancy of the implementers to participate in the program. CDC has 

indicated that it is developing cost estimates and working to identify 

additional resources to support implementation. In late March, HHS 

announced that jurisdictions would be allowed to obtain up to 20 percent 

of their 2003 federal bioterrorism preparedness funding immediately upon 

approval of their application by CDC. One of the activities that this funding 

may be requested for is smallpox vaccination. As of late April, the 

application procedure for obtaining these funds had not been specified. 

With regard to the liability concerns, CDC officials reported that they have 

Major Challenges 

Have Not Been 

Overcome and 

Continue to Affect 

Implementation 
Page 23 GAO-03-578 National Smallpox Vaccination Program 

worked with HHS to clarify the scope of the protection provided by the 

Homeland Security Act of 2002. HHS issued a letter and a declaration from 

the Secretary, and CDC published guidance and question-and-answer 

documents. Nonetheless, implementers continue to have questions and say 

they would prefer changes in the act itself to be assured of liability 

protection. 

In addition, Congress has taken steps to address implementers’ concerns 

about resources. On April 16, 2003, legislation was enacted appropriating 

$100 million to the Public Health and Social Services Emergency Fund 

intended to support implementation of the smallpox vaccination 

program.34 However, because CDC still has not estimated costs, it is 

unclear whether these funds will be sufficient to address the resource 

concerns of the implementers. Furthermore, details on how funds will be 

made available to jurisdictions have yet to be outlined. 

Although CDC is working to address the volunteers’ safety concerns that 

are leading to their hesitancy to participate, some concerns have not been 

resolved to the volunteers’ satisfaction. CDC has decided not to change its 

guidance on several safety issues important to volunteers but has agreed 

to study some of these issues further. For example, it has not changed its 

recommendation that health care workers do not need to be routinely 

separated from patients while they are capable of transmitting vaccinia 

virus because it maintains that if the recommended safety measures, such 

as special bandaging, are followed they will provide sufficient protection. 

Further, CDC said that in making its decision about whether to change the 

needles provided with the vaccine kits, it reviewed an HHS evaluation of 

the alternative needle and concluded it was not safer. It does not intend to 

change the needles at this time, but it does intend to study the issue 

further and in the meantime to monitor unintentional needlesticks. Finally, 

CDC has not changed its recommendations regarding the provision of 

testing for pregnancy and HIV as part of the screening process. Thus, it is 

still at the discretion of jurisdictions to provide such testing routinely and 

free of charge. CDC plans to maintain a registry of pregnant women who 

may have been exposed to smallpox vaccine. Volunteers are, however, still 

concerned about these safety issues. 

 34Emergency Wartime Supplemental Appropriations Act, 2003, Pub. L. No. 108-11, 117 Stat. 

559, 586 (2003). The Conference Committee Report states that this amount is to assist state 

and local health authorities with costs associated with the smallpox vaccination program. 

H.R. Conf. Rep. No. 108-76, at 86 (2003). 
Page 24 GAO-03-578 National Smallpox Vaccination Program 

Congress has taken steps to address volunteers’ compensation concerns. 

On April 24, 2003, it presented legislation to the President for his signature 

to create a smallpox vaccination compensation program. This program 

would provide benefits to public health and health care response team 

members participating in a smallpox emergency response plan and public 

safety personnel who are injured as a result of receiving the smallpox 

vaccine.35 Organizations representing public health and health care 

workers have reacted positively to the new legislation. Other legislation 

that addresses challenges facing the smallpox vaccination program in 

addition to compensation, such as the safety concerns raised by 

volunteers, has been introduced in the House of Representatives.36

We recognize that CDC and the jurisdictions have been trying to mount a 

large effort in a short time. The National Smallpox Vaccination Program is 

unprecedented and complex. Our public health system has not had 

experience with either smallpox or smallpox vaccination in over 30 years. 

Further, the context for the program is one of great uncertainty about both 

the risk of a smallpox attack and the individual health risks involved in 

vaccination. 

As might be expected with such a complex program, challenges have been 

encountered. Implementers and volunteers have indicated that they are 

unlikely to participate in the smallpox vaccination program in the numbers 

needed to achieve the initial targets unless their major concerns have been 

addressed. Because many concerns remain unresolved, it may be difficult 

to achieve the initial targets for the first stage. It is also too soon to 

evaluate the impact on participation in the program of steps that have 

been taken to provide additional resources and compensation for injuries. 

However, CDC and some of the jurisdictions have indicated that as the 

program unfolds and they learn more, they are less concerned about 

achieving their initial targets and are considering revising them. However, 

if the estimates are reduced for the numbers and types of vaccinated 

health workers in Smallpox Response Teams, CDC would need to provide 

guidance to ensure that smaller or fewer teams are organized and 

 35Smallpox Emergency Personnel Protection Act of 2003, H.R. 1770, 108th Cong. (2003) 

(enrolled). 

36Smallpox Vaccine Compensation and Safety Act of 2003, H.R. 865, 108th Cong. (2003) 

(introduced). 

Conclusions 
Page 25 GAO-03-578 National Smallpox Vaccination Program 

distributed in a manner that will provide adequate response capacity—that 

is, the capacity to effectively investigate an outbreak, care for patients, and 

vaccinate members of the public. Setting revised targets for the total 

number of vaccinations necessary would also provide a basis for more 

accurately estimating what is needed to address the major concerns of 

implementers and volunteers regarding resources, liability, and 

compensation for adverse events. 

A change in targets for the first stage would likely have implications for 

the second stage. CDC has not provided guidance for determining how the 

workers to be vaccinated in the second stage will be used to expand 

response capacity. Thus it may be difficult for the jurisdictions to estimate 

targets and plan implementation of the second stage. 

With regard to the top priority for implementation—safety—the important 

questions cannot yet be answered. To answer these questions and ensure 

that program implementation proceeds through the first stage as safely as 

possible, CDC and the jurisdictions need to collect and analyze data on an 

ongoing basis. To date, not enough data have been collected to provide the 

needed information. Answers to these questions are also important for 

ensuring safe expansion to as many as 10 million additional volunteers in 

the second stage of the program. 

To ensure that the National Smallpox Vaccination Program successfully 

develops adequate response capacity for a potential terrorist attack 

involving smallpox, we recommend that the Director of CDC 

• provide guidance and specific parameters to the jurisdictions for 

estimating response capacity needs and work with the jurisdictions to 

revise local and national targets for the first stage and 

• provide guidance to the jurisdictions for implementing the second stage of 

the program. 

In its comments on a draft of this report, CDC concurred with our 

recommendations, and indicated that it will issue guidance to assist 

jurisdictions in their efforts to identify, train, and vaccinate appropriate 

responders (see appendix I). CDC also provided technical comments, 

which we incorporated as appropriate. 

Recommendations 

Agency Comments 
Page 26 GAO-03-578 National Smallpox Vaccination Program 

We are sending copies of this report to the Director of CDC and other 

interested officials. We will also provide copies to others upon request. In 

addition, the report will be available at no charge on GAO’s Web site at 

http://www.gao.gov. If you or your staff have any questions about this 

report, please call me at (202) 512-7119. Another contact and key 

contributors are listed in appendix II. 

Sincerely yours, 

Marcia Crosse 

Acting Director, Health Care—Public 

 Health and Science Issues 
Appendix I: Comments from the Centers for Disease Control and Prevention 

Page 27 GAO-03-578 National Smallpox Vaccination Program 

Appendix I: Comments from the Centers for 

Disease Control and Prevention 
Appendix I: Comments from the Centers for Disease Control and Prevention 

Page 28 GAO-03-578 National Smallpox Vaccination Program 
Appendix II: GAO Contact and Staff 

Acknowledgments 

Page 29 GAO-03-578 National Smallpox Vaccination Program 

Michele Orza, (202) 512-6970 

Other key contributors to this report are George Bogart, Barbara 

Chapman, Angela Choy, Chad Davenport, Nkeruka Okonmah, and 

Roseanne Price. 

Appendix II: GAO Contact and Staff 

Acknowledgments 

GAO Contact 

Acknowledgments 
Related GAO Products 

Page 30 GAO-03-578 National Smallpox Vaccination Program 

Bioterrorism: Preparedness Varied across State and Local Jurisdictions. 

GAO-03-373. Washington, D.C.: April 7, 2003. 

Homeland Security: Voluntary Initiatives Are Under Way at Chemical 

Facilities, but the Extent of Security Preparedness Is Unknown. GAO-03-

439. Washington, D.C.: March 14, 2003. 

Weapons of Mass Destruction: Observations on U.S. Threat Reduction 

and Nonproliferation Programs in Russia. GAO-03-526T. Washington, 

D.C.: March 5, 2003. 

Food-Processing Security: Voluntary Efforts Are Under Way, but Federal 

Agencies Cannot Fully Assess Their Implementation. GAO-03-342. 

Washington, D.C.: February 14, 2003. 

Chemical and Biological Defense: Observations on DOD’s Risk 

Assessment of Defense Capabilities. GAO-03-137T. Washington, D.C.: 

October 1, 2002. 

Anthrax Vaccine: GAO’s Survey of Guard and Reserve Pilots and 

Aircrew. GAO-02-445. Washington, D.C.: September 20, 2002. 

Bioterrorism: The Centers for Disease Control and Prevention’s Role in 

Public Health Protection. GAO-02-235T. Washington, D.C.: November 15, 

2001. 

Bioterrorism: Review of Public Health Preparedness Programs. GAO-02-

149T. Washington, D.C.: October 10, 2001. 

Bioterrorism: Public Health and Medical Preparedness. GAO-02-141T. 

Washington, D.C.: October 9, 2001. 

Bioterrorism: Coordination and Preparedness. GAO-02-129T. 

Washington, D.C.: October 5, 2001. 

Bioterrorism: Federal Research and Preparedness Activities. GAO-01-

915. Washington, D.C.: September 28, 2001. 

Chemical and Biological Defense: Improved Risk Assessment and 

Inventory Management Are Needed. GAO-01-667. Washington, D.C.: 

September 28, 2001. 

Related GAO Products 
Related GAO Products 

Page 31 GAO-03-578 National Smallpox Vaccination Program 

Occupational Safety: Selected Cost and Benefit Implications of 

Needlestick Prevention Devices for Hospitals. GAO-01-60R. Washington, 

D.C.: November 17, 2000. 

Food Safety: Agencies Should Further Test Plans for Responding to 

Deliberate Contamination. GAO/RCED-00-3. Washington D.C.: 

October 27, 1999. 

Combating Terrorism: Need for Comprehensive Threat and Risk 

Assessments of Chemical and Biological Attacks. GAO/NSIAD-99-163. 

Washington, D.C.: September 14, 1999. 

Chemical and Biological Defense: Program Planning and Evaluation 

Should Follow Results Act Framework. GAO/NSIAD-99-159. Washington, 

D.C.: August 16, 1999. 

Combating Terrorism: Observations on Biological Terrorism and Public 

Health Initiatives. GAO/T-NSIAD-99-112. Washington, D.C.: March 16, 

1999. 

(290262) 
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